Zydus to begin manufacturing the medication at its state-of-the-art facility located in Ahmedabad

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (US FDA) to produce Methenamine Hippurate Tablets USP, 1 gram (branded as Hiprex Tablets in the US). This approval allows Zydus to begin manufacturing the medication at its state-of-the-art facility located in Ahmedabad, India (SEZ).

Methenamine Hippurate tablets are primarily used for the long-term prophylactic or suppressive treatment of recurrent urinary tract infections. This treatment is particularly beneficial for patients who experience frequent UTIs and require ongoing therapy to prevent further episodes. According to IQVIA data for January 2025, the US market for Methenamine Hippurate tablets has an annual sales value of approximately $32.6 million.

This latest approval brings Zydus' total number of USFDA approvals to 419. Since its inception in the fiscal year 2003-04, the company has filed 483 Abbreviated New Drug Applications (ANDAs), further strengthening its commitment to expanding its global pharmaceutical presence.